MSD Associate Director Bioprocess Lead MS & 

Ireland, Dublin 

710240056

Job Description

What you will do:

Reporting to the Manufacturing Science & Technology Laboratory Lead, the responsibilities include, but are not limited to the following:

• Manage, coach, and mentor the MS&T drug substance team inperforming advanced technical experiments.Inspire, reward, and develop individuals, helping them to reach their potential.
• Technical Lead for MS&T Process Sciences and the site.
• To provide proactive, technical oversight of the biologics inline & pipeline products.
• Lead technical assessments for process investigations, risk assessments, evaluation of specifications and material qualification.
• Coach the team on development and execution of technical studies, continuous improvement of existing biologics processes and for new product launch.

• Complete experimental design, execution, data analysis and interpretation for improvement programs.
• Oversight of the product robustness trends observed in commercial operations and alignment with laboratory models, such as SIMCA for multivariate data analyses.
• Lead and/or support deployment and use of various digital tools at Biotech Dublin facility: Leverage these tools to deliver business value through predictive/proactive issue resolution, rapid investigation closure, improved yield/throughput.
• Assist in the regulatory authoring and review of technical documentation, technical report writing and global regulatory submissions.
• Support creation of the laboratory budget and review actual performance against forecast.

What skills you will need:

• Ideally a Master’s in Biological Sciences/ Chemical Engineering/ BiologicalEngineering/Chemistry.
• 8+ years directly related working knowledge in academia, pharmaceutical or biotechnology company – along with a working familiarity of current regulatory requirements and current Good Manufacturing Practices.
• The successful candidate will also have demonstrated the ability to deliver projects and programs, with a strong understanding of lean and laboratory operations.
• Excellent oral and written communication skills, with the ability to effectively articulate understanding of process science to drive decision making, impact assessments, design of studies in a multi-disciplinary team environment.

So, if you are ready to:

Current Contingent Workers apply

Not Applicable

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